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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2 MODULE PUMP, INFUSION

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CAREFUSION SD 8300 ALARIS ETCO2 MODULE PUMP, INFUSION Back to Search Results
Model Number 8300
Device Problems Break (1069); Contamination (1120); Crack (1135); Failure to Calibrate (2440); Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer reported problem was confirmed. The device was repaired, passed all require testing and specifications and released back to the customer. A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue. A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode. The customer stated that there was no patient involvement.
 
Event Description
(b)(4). Damaged/cracked in case front, case rear. Failed co2 cal test in oridion board. Other- specify in comments. Isolation rib damage in iui. Contamination in iui.
 
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Brand Name8300 ALARIS ETCO2 MODULE
Type of DevicePUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
priya prabhakaran santha
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11270671
MDR Text Key230228482
Report Number2016493-2021-22429
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8300
Device Catalogue Number8300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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